The following data is part of a premarket notification filed by Sub-q, Inc. with the FDA for Qs Delivery System.
Device ID | K991254 |
510k Number | K991254 |
Device Name: | QS DELIVERY SYSTEM |
Classification | Syringe, Irrigating (non Dental) |
Applicant | SUB-Q, INC. 1062-D CALLE NEGOCIO San Clemente, CA 92673 |
Contact | Dan W Miller |
Correspondent | Dan W Miller SUB-Q, INC. 1062-D CALLE NEGOCIO San Clemente, CA 92673 |
Product Code | KYZ |
CFR Regulation Number | 880.6960 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1999-04-13 |
Decision Date | 1999-08-23 |